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A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia

NCT ID: NCT05657574

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-24

Study Completion Date

2023-06-30

Brief Summary

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This is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of CKD-391 and CKD-331 in patients with primary hypercholesterolemia

Detailed Description

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Participants were randomly assigned in a 1:1:1:1 ratio to the following groups: combination therapy of D377 and CKD-331, D377, CKD-331, and D086. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 8 weeks.

Conditions

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Primary Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CKD-391

D377 + CKD-331 + placebo (for D086)

Group Type EXPERIMENTAL

D377

Intervention Type DRUG

oral, once daily, 8 weeks

CKD-331

Intervention Type DRUG

oral, once daily, 8 weeks

Placebo (for D086)

Intervention Type DRUG

oral, once daily, 8 weeks

CKD-331

CKD-331 + placebo (for D377) + placebo (for D086)

Group Type ACTIVE_COMPARATOR

CKD-331

Intervention Type DRUG

oral, once daily, 8 weeks

Placebo (for D377)

Intervention Type DRUG

oral, once daily, 8 weeks

Placebo (for D086)

Intervention Type DRUG

oral, once daily, 8 weeks

D377

D377 + placebo (for CKD-331) + placebo (for D086)

Group Type ACTIVE_COMPARATOR

D377

Intervention Type DRUG

oral, once daily, 8 weeks

Placebo (for CKD-331)

Intervention Type DRUG

oral, once daily, 8 weeks

Placebo (for D086)

Intervention Type DRUG

oral, once daily, 8 weeks

D086

D086 + placebo (for D377) + placebo (for CKD-331)

Group Type ACTIVE_COMPARATOR

D086

Intervention Type DRUG

oral, once daily, 8 weeks

Placebo (for D377)

Intervention Type DRUG

oral, once daily, 8 weeks

Placebo (for CKD-331)

Intervention Type DRUG

oral, once daily, 8 weeks

Interventions

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D377

oral, once daily, 8 weeks

Intervention Type DRUG

CKD-331

oral, once daily, 8 weeks

Intervention Type DRUG

D086

oral, once daily, 8 weeks

Intervention Type DRUG

Placebo (for D377)

oral, once daily, 8 weeks

Intervention Type DRUG

Placebo (for CKD-331)

oral, once daily, 8 weeks

Intervention Type DRUG

Placebo (for D086)

oral, once daily, 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults ≥ 19 years of age
* Primary hypercholesterolemia
* Patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator

Exclusion Criteria

* Secondary hypercholesterolemia
* Conditions / situations such as:

1. Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels
2. Severe renal impairment or active liver disease
* History of hypersensitivity or allergies to investigational drugs or drug of similar chemical classes.
* History of drug abuse or alcoholism within 24 weeks before screening
* Any surgical or medical condition which might significantly affect the absorption, distribution, metabolism, or excretion of investigational drugs
* Patients who have been taken with other investigational drugs within 8 weeks before screening
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SeungHwan Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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SeungHwan Lee, MD

Role: CONTACT

Phone: +82-2-3010-4829

Email: [email protected]

Facility Contacts

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SeungHwan Lee, MD

Role: primary

Other Identifiers

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A52_08HCL2217

Identifier Type: -

Identifier Source: org_study_id